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NCT ID: NCT02968901 Terminated - Clinical trials for Pulmonary Arterial Hypertension

Clinical Study Evaluating the Effects of First-line Oral cOmbination theraPy of maciTentan and tadalafIl in Patients With Newly Diagnosed pulMonary Arterial Hypertension (OPTIMA)

OPTIMA
Start date: September 1, 2015
Phase: Phase 4
Study type: Interventional

The purpose of the study is to document the effect of first line dual oral combination therapy with macitentan 10mg and tadalafil 40mg on pulmonary vascular resistance (PVR) in treatment-naïve patients with newly diagnosed pulmonary arterial hypertension (PAH).

NCT ID: NCT02966119 Terminated - Cerebral Hemorrhage Clinical Trials

REstart or STop Antithrombotic Randomised Trial in France

RESTART-Fr
Start date: December 7, 2016
Phase: Phase 3
Study type: Interventional

RESTART- fr is a randomised controlled trial for adults surviving spontaneous intracerebral haemorrhage who had taken an antithrombotic drug (i.e. anticoagulant or antiplatelet medication) for the prevention of vaso-occlusive disease before the ICH. RESTART- fr is testing whether a policy of starting antiplatelet drugs (one or more of aspirin, clopidogrel, or dipyridamole, chosen at investigator's discretion) results in a beneficial net reduction of all serious vascular events over two years compared with a policy of avoiding antiplatelet drugs.

NCT ID: NCT02965846 Terminated - Dry Eye Syndromes Clinical Trials

Topical Ophthalmic AGN-195263 for the Treatment of Evaporative Dry Eye

Start date: December 13, 2016
Phase: Phase 3
Study type: Interventional

The objectives of this study are twofold •To evaluate the safety and efficacy of 0.1% AGN-195263 administered twice daily compared to its vehicle in patients with evaporative dry eye (EDE) •To evaluate the systemic pharmacokinetics of 0.1% AGN-195263 administered twice daily in patients with EDE

NCT ID: NCT02964546 Terminated - Atrial Fibrillation Clinical Trials

Glomerular Filtration Rate-Estimating Equations During Use of Direct Oral Anticoagulants in Elderly Patients

REINACO
Start date: June 8, 2015
Phase:
Study type: Observational

Atrial fibrillation in the elderly is a complex condition due to the high number of frequently associated comorbidities such kidney disease. Direct oral anticoagulants (dabigatran, rivaroxaban and apixaban) are indicated for preventing thromboembolic events but renal function should be closely monitored for this age group when these drugs are used. Dosing recommendations for prevention of stroke are based on renal clearance of creatinine (ClCr) estimated using the Cockcroft-Gault formula. It is well known that ClCr estimates predict a steeper decline with advancing age than Glomerular Filtration Rate (GFR) estimates. This raises the possibility that substitution of commonly reported GFR for estimated CrCl could result in different plasmatic concentrations of oral direct anticoagulants. The aim of this study was to compare estimates of ClCr and GFR and determine the impact on the plasmatic concentration of these drugs in elderly patients with non-valvular atrial fibrillation.

NCT ID: NCT02964507 Terminated - Neoplasms Clinical Trials

Dose Escalation and Expansion Study of GSK525762 in Combination With Fulvestrant in Participants With Hormone Receptor-positive (HR+)/Human Epidermal Growth Factor Receptor 2 Negative (HER2-) Advanced or Metastatic Breast Cancer

Start date: February 2, 2017
Phase: Phase 1
Study type: Interventional

This is a combination Phase I and Phase II study, with an aim to evaluate the combination of GSK525762 and fulvestrant in women with HR+/HER2- advanced or metastatic breast cancer, who have disease that has progressed after prior treatment with at least one line of endocrine therapy. The objectives of the study are to first identify, in open-label single-arm Phase I, a recommended Phase II dose of GSK525762 that may be combined safely with fulvestrant. Phase I will follow a modified toxicity probability interval (mTPI) design, and a sentinel group will be evaluated first for dose-limiting toxicity and further expanded to collect additional safety data. This will be followed by a double-blind, randomized controlled Phase II, to identify the clinical activity of the two study treatments when given in combination. The composition of Phase II will be selected at the end of Phase I.

NCT ID: NCT02963363 Terminated - Clinical trials for HER2 Positive Breast Cancer

Adapted Physical Activity for Breast Cancer HER2 Positive Patient

APACAN2
Start date: April 27, 2018
Phase: N/A
Study type: Interventional

The purpose of this study is to assess the feasibility of a home-based adapted physical activity during neoadjuvant chemotherapy for HER2+ breast cancer.

NCT ID: NCT02962388 Terminated - Clinical trials for Essential Thrombocythemia

The Ruxolitinib Versus Best Available Therapy Trial in Patients With High Risk ET in Second Line

Start date: January 3, 2017
Phase: Phase 2/Phase 3
Study type: Interventional

Prospective national multicenter randomized open label phase IIb RUXBETA trial.

NCT ID: NCT02960217 Terminated - Clinical trials for Glucose Transporter Type 1 Deficiency Syndrome (Glut1 DS)

Crossover Study to Assess the Efficacy and Safety of UX007 in the Treatment of Movement Disorders Associated With Glucose Transporter Type 1 Deficiency Syndrome (Glut1 DS)

Start date: April 19, 2017
Phase: Phase 3
Study type: Interventional

The primary objective of the study was to evaluate the efficacy and safety of UX007 in the treatment of disabling paroxysmal movement disorders associated with Glut1 DS.

NCT ID: NCT02960191 Terminated - Suicidal Behavior Clinical Trials

Functional Neuroimaging and Genetic Vulnerability to Suicidal Behavior

Start date: December 2008
Phase: N/A
Study type: Interventional

The main objective is to highlight, by functional imaging (MRI) dysfunctional brain regions associated with vulnerability to suicidal behavior.

NCT ID: NCT02957617 Terminated - Clinical trials for Neuropathic Pain From Lumbosacral Radiculopathy

Extension Study to Evaluate the Long-Term Safety, Tolerability, and Maintenance of Effect of BIIB074

RELAY-1 Extend
Start date: February 10, 2017
Phase: Phase 2
Study type: Interventional

The primary objective of the study is to evaluate the long-term safety and tolerability of BIIB074 in participants with neuropathic Pain From Lumbosacral Radiculopathy (PLSR). A secondary objective is to investigate the maintenance of effect during long-term treatment with BIIB074 in participants with neuropathic PLSR. For all efficacy assessments, baseline will be prior to randomization into Study 1014802-203. Another secondary objective is to evaluate the impact of treatment with BIIB074 on quality of life (QoL).